Monday, July 30, 2012

PROP Petitions the FDA on Opiates

Physicians for Responsible Opioid Prescribing (PROP) has petitioned the FDA to modify the warnings about opioids. They cite the well known dimensions of the current epidemic including a four fold increase in opioid prescribing and a four fold increase in opioid related overdose deaths. They also cite numerous references about the real risks of prescribing opioids for chronic non cancer pain with very little guidance.

PROP highlights a big problem in medical research and associated public policy and that is the biasing influence of the pharmaceutical industry and a few people at the top. The Institute of Medicine was instrumental in highlighting the issue of chronic pain and framing it as a discrete disease. Although not mentioned specifically by PROP, the Joint Commission (then known as JCAHO) promoted pain recognition and treatment in the year 2000. As this excerpt shows that initiative did not go well.

"In 2001, the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) introduced the concept that pain was the “fifth vital sign,” in an effort to increase the awareness of pain in the hospitalized patient, and by design, improve the treatment of that pain. Unfortunately, the current emphasis on pain assessment as the fifth vital sign has resulted in the potential overmedication of a group of patients (139)" (see ref 1).Without going into detail at this time, I think that are recurrent patterns of federal and state governments, the managed care industry, and the pharmaceutical industry and their affiliated organisations driving practice patterns and treatment guidelines based on very little evidence. That culminates in broad initiatives like the PPACA that are widely hyped as advances in medical treatment, but they are basically an experiment in medicine founded on business and financial rather than scientific principles. There may be no better example than the practice of prescribing opioids for chronic non cancer pain.
Another contrast for this essay is the comparison with what has been years of psychiatric criticism based on the same principles. The basic argument from the media, antipsychiatrists, generic psychiatric critics, and grandstanding politicians has been that the pharmaceutical industry has been able to financially influence psychiatrists to prescribe drugs that are at the best worthless or at the worst downright dangerous (their characterizations). That despite the fact that black box warnings on psychiatric medication may be held to a much higher standard than other medication even if they target the same level of morbidity and mortality. After all, there is no known psychiatric medication that is mass prescribed and has resulted in overdose deaths at the rate that people are currently dying from prescribed opioids.

Just a few weeks ago, the FDA posted a number of initiatives on their web site focused on the prescription of extended release opioids. My read through the most detailed document shows that it does not touch on the principles outlined by PROP. The idea that this is strictly a matter of educating physicians is an oversimplification. This is a matter of creating initiatives that governments and sanctioning bodies insist that physicians follow and then coming up with other rules when the original ideas fail.